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Protopic Side Effects

Protopic eczema cream may cause cancer

–March 10, 2005

Evidence based on animal studies indicated Protopic side effects might include cancer, such as lymphoma and skin cancer. FDA said research had shown the cancer Protopic side effects risk might occur when it is absorbed into the body. Protopic is usually applied topically through a cream.

The drug agency said it could take human studies of ten years or longer to determine if use of the eczema cream is linked to cancer, and until then, the Protopic side effects risks are uncertain at this time. The FDA has ordered a "black box" warning be placed on the drug's labeling, warning of the potentially dangerous Protopic side effects. A black box warning is the FDA's most severe drug warning.

The agency has also recommended that because of the risk of potentially serious Protopic side effects, the drug should only be used for patients who have failed treatment with other therapies first. Children under the ages of two should not be treated with the cream at all because the agency said there is not enough information on Protopic side effects among infants and children with developing immune systems.

In February, members of an FDA advisory panel said they were concerned with companies, such as Protopic manufacturer Fujisawa Pharmaceuticals, aggressively advertising eczema creams to treat infants and others with skin problems the creams were not approved to treat. Based on the FDA Pediatric Advisory Committee's advice, the FDA will require labeling changes will be made, warning of potentially serious Protopic side effects like cancer.

Please contact a Protopic Lawyer if you would like more information on Protopic Side Effects and your legal rights and options.

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